03:21 , Nov 17, 2018 |  BioCentury  |  Product Development

Betting Combos on Biomarkers

Despite lackluster monotherapy data at SITC from the latest tranche of immunotherapy candidates, drug developers are moving into combination trials with PD-1 and PD-L1 inhibitors based on biomarkers of pharmacodynamic activity. Results from the next...
22:19 , Nov 16, 2018 |  BC Extra  |  Company News

CHMP backs first all-oral sleeping sickness treatment, extensions for Blincyto, Opdivo-Yervoy combo

EMA's CHMP recommended a basket of approvals and label extensions on Friday, including the first all-oral treatment for African trypanosomiasis (sleeping sickness). The agency issued no negative opinions in its monthly roundup. The agency backed...
18:10 , Nov 9, 2018 |  BC Week In Review  |  Company News

Genentech seeks to block JHL from using trade secrets

Genentech Inc. is asking a federal court to block JHL Biotech Inc. (Zhubei, Taiwan) from making and selling products the company claims benefited from its proprietary information, following the indictment of three former Genentech employees...
00:40 , Nov 8, 2018 |  BC Extra  |  Company News

Genentech seeks to block JHL from using trade secrets

Genentech Inc. is asking a federal court to block JHL Biotech Inc. (Zhubei, Taiwan) from making and selling products the company claims benefited from its proprietary information, following the indictment of three former Genentech employees...
18:27 , Oct 19, 2018 |  BC Week In Review  |  Company News

Roche culls pipeline, cuts include in-licensed, acquired programs

Roche (SIX:ROG; OTCQX:RHHBY) announced in its 3Q18 earnings it discontinued development of five new molecular entities, including Phase II rheumatoid arthritis candidate RG6125 (SDP051), plus two programs in development for follow-on indications. The pharma lost...
21:29 , Oct 17, 2018 |  BC Extra  |  Company News

Roche culls pipeline, cuts include in-licensed, acquired programs

Roche (SIX:ROG; OTCQX:RHHBY) announced in its 3Q18 earnings it discontinued development of five new molecular entities, including Phase II rheumatoid arthritis candidate RG6125 (SDP051), plus two programs in development for follow-on indications. The pharma lost...
20:39 , Oct 5, 2018 |  BC Week In Review  |  Company News

U.K. judge upholds preferred prescribing of Avastin off label for wet AMD

A U.K. judge upheld in September a policy of prescribing Avastin bevacizumab as the preferred treatment option for wet age-related macular degeneration (AMD) over Eylea aflibercept and Lucentis ranibizumab. Avastin does not have marketing authorization...
15:18 , Sep 14, 2018 |  BC Week In Review  |  Company News

GNS, Amgen to use AI to explore patient response to mCRC drug Vectibix

GNS Healthcare Inc. (Cambridge, Mass), Amgen Inc. (NASDAQ:AMGN) and the Alliance for Clinical Trials in Oncology (Boston, Mass.) partnered to use artificial intelligence to identify factors that drive and predict patient responses to Amgen’s metastatic...
18:07 , Sep 7, 2018 |  BC Week In Review  |  Clinical News

FDA extends review of Tecentriq/Avastin combo for NSCLC

Roche (SIX:ROG; OTCQX:RHHBY) said FDA extended review for an sBLA for Tecentriq atezolizumab by three months to Dec. 5. The original PDUFA date was Sept. 5. The sBLA , which FDA is evaluating under Priority...
23:11 , Aug 28, 2018 |  BC Extra  |  Company News

Management tracks: BMS, Roche

Bristol-Myers Squibb Co. (NYSE:BMY) said Christopher Boerner will become EVP and Chief Commercial Officer. He succeeds Murdo Gordon, who departed the company last month to become EVP of global commercial operations at Amgen Inc. (NASDAQ:AMGN)...